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FCR CAPSULA XL II with Imaging Plate HR-VI has cleared FDA** / 510k*** for mammography applications in the U.S.A market as “ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)”. The “ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)” is a full-field digital mammography system consisting of the three main components;
FCR Capsula XLII (CR-IR 359), Imaging Plate HR-VI and Console (CR-IR 348 CL).

Notes

*In the U.S. and Canada the unit cannot be applicable to mammography. In other countries, the locally applicable regulations and/or guidelines should be followed.

**FDA (U.S. Food and Drug Administration)

***510k (Premarket submission made to FDA) FCR CAPSULA XLII with Imaging Plate HR-VI has complied to basic concept and limiting values of Europian guidelines for quality assurance in breast cancer screening and diagnosis (Fourth Edition of EUREF) tested by Helmholz, German Reserch Center.

Features

One of the FCR key components is an Imaging Plate, or IP, that is used in place of X-ray film to easily digitize X-ray images. The FCR CAPSULA XLII features the IP in an unprecedented compact frame, as it incorporates over 70 years of Fujifilm's extensive technology and know-how.

CAPSULA, meaning small box in Latin, has been cleverly trimmed to be smaller and lighter, boosting flexibility on installation and layout, while maintaining the specifications for a broad range of diagnostic imaging needs from general radiography to pantomography. Plus, the optional capability of 50-micron reading with the HR-V or HR-VI can be utilized to visualize finer and more minute structures for better diagnosis.

Compact with high efficiency

FCR CAPSULA XLII enables extremely high throughput of up to approximately 94 IPs/hr.* and the time to display the image on the CR Console monitor is approximately 23 sec., in spite of its compactness.

All-in-one unit for all diagnostic imaging needs

Three types of IP cassettes (Type CC, LC and CH**) can cover various imaging such as chest, lumbar spine, pantomography (15 × 30 cm), and extremities. Virtually all imaging requirements can be satisfied with the single unit.

Easy operations monitored on screen

Capable of automatically starting the IP reading and image processing when the IP cassette is inserted, the system is designed to complete the IP reading cycle with simple operations. Setting parameters can be changed with the buttons on the monitor screen. The screen can also display the status and the time remaining to complete the IP reading process for user-convenience.

Image display and processing — CR Console

The multi-function console handles all complex procedures of digital X-ray imaging — patient ID, image reviewing, processing and printing, DICOM interface, and more — as well as quality assurance functions all within a single workstation.

Image quality improvement

Compatible with MAMMOASCENT AWS-c

The MAMMOASCENT AWS-c optimizes your mammography examinations with its advanced design and features. Correspondence to Fujifilm Mammography QC Program with 1 shot phantom.

Compatible with Fujifilm Mammography QC Program

Fujifilm Mammography QC Program is a dedicated quality control program applicable to Fujifilm digital mammography system. This program enables the system to keep a stable image quality for both screening and diagnosis.

Notes

*When a 35 × 35 cm (14″ × 14″ ) IP is read at 5 pixels/mm.

**The optional 50-micron reading kit with HR-V or HR-VI necessary

***In the Canadian market, the unit cannot be applicable to mammography. In other countries, the local applicable regulations and /or guidelines should be followed.

*4CAPSULA XLII with HR-VI has cleared FDA/510k for mammography applications. Using HR-VI required specific version of Software.

IP Cassette

Notes

*Not for Mammography application

**Requires the optional upgrade kit and the cassette adaptor

***Requires the optional upgrade kit

Specifications are subject to change without notice.
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